Generics Industry News Search
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July 2010 News Archive |
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Lupin Limited announced today that its U.S subsidiary, Lupin Pharmaceuticals, Inc. (LPI) has received final approval for the company's Abbreviated New Drug Application (ANDA) for Famotidine for Oral Suspension (40 mg / 5 mL) from the US Food and Drug Administration (FDA). Commercial shipments of the product have already commenced....
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Sun Pharma announced launch of generic Exelon, rivastigmine tartrate capsules for the US market. Earlier, USFDA had granted final approval for the Company's ANDA to market these products....
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Teva Pharmaceutical Industries Ltd. announced today that it has commenced commercial launch of Venlafaxine HCl ER Capsules, the Company's generic version of Wyeth's antidepressant Effexor XR. The brand product had annual sales of approximately $2.75 billion in the United States, based on IMS sales data....
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Watson Pharmaceuticals, Inc. announced today that, under a settlement with Novartis Pharmaceuticals Corporation, Novartis Pharma AG, Novartis AG, Novartis International Pharmaceutical Ltd., and Proterra AG (collectively "Novartis"), Watson has commenced shipment of a generic version of Exelon(R) (rivastigmine tartrate) 1.5mg, 3mg, 4.5mg and 6mg capsules....
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Par Pharmaceutical Companies, Inc. today announced that it began shipping the 20mg/1100mg and 40mg/1100mg strengths of omeprazole and sodium bicarbonate capsules to the trade....
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Prasco Laboratories announced today that it is now shipping the authorized generic version of ZEGERID(R) (omeprazole/sodium bicarbonate) capsules....
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The European Union's second-highest court upheld a ruling that AstraZeneca Plc misled patent officials and flouted antitrust rules to keep a generic competitor off the market, while reducing the associated fine against the company.
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Impax Laboratories, Inc. today confirms that it has initiated a challenge of a patent listed by Genzyme Corporation in connection with RENVELA, 2.4 g and 0.8 g....
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Watson Pharmaceuticals, Inc., today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application for Tacrolimus 5 mg capsules, the generic equivalent to Astellas' Prograf capsules....
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Daiichi Sankyo Company Limited and Ranbaxy Laboratories Limited announced today that Ranbaxy's New Drug Discovery Research has been transferred to Daiichi Sankyo India Pharma Private Limited as part of the strategy to strengthen the global Research and Development (R&D;) structure of the Daiichi Sankyo Group....
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High development costs, complex manufacturing and legal hurdles are holding back generic drugmakers seeking to copy pricey biotech medications nearing the end of their patents...
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Big drug manufacturers could face further scrutiny by Europe's top watchdog after a probe into recent patent settlements with generic counterparts showed that nine deals - or 10 per cent of the total - -were potentially "problematic".
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The generic drugmaker Eurofarma has further consolidated its presence in the Latin American market with the acquisition of Laboratorios Gautier - the seventh largest pharmaceutical company in Uruguay, which is also present in Paraguay and Bolivia...
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The Drug Price Competition Act and Patent Term Restoration Act of 1984, commonly known as the Waxman-Hatch Act, created a streamlined procedure for the approval and marketing of generic drugs through the filing of an abbreviated new drug application (ANDA). Before the enactment of Waxman-Hatch, the Food and Drug Administration (FDA) approved drugs only pursuant to a new drug application (NDA), which required that the applicant prove the safety and efficacy of its drug through extensive clinical testing. ...
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Loon Gangte, head of the Delhi Network of Positive People and a leader in the campaign to defend HIV-Aids sufferers, fears that negotiations between the EU and India on a free trade agreement, to be completed by the end of the year, will undermine India's booming generic drug business and jeopardise cheap treatment....
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Drug maker Sigma Pharmaceuticals Ltd says it has not received any formal proposal from South Africa's Aspen Pharmacare but Aspen wished to continue conducting due diligence
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The Food and Drug Administration has approved a topical drug for acne made by E. Fougera, the generic drug maker said Tuesday...
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The US House of Representatives passed on July 1, 2010, HR 4899, the Supplemental Appropriations Act of 2010, which included provisions restricting patent settlements between innovator-drug and generic-drug companies...
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A New Jersey federal district court judge slapped Indian generics maker Glenmark Pharmaceuticals with sanctions on Thursday, ruling that the company destroyed more than a year's worth of potential evidence as a patent battle...
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In litigation with the Canadian generic manufacturer Apotex over its multibillion dollar cholesterol drug Lipitor, Pfizer failed to win the dismissal of Apotex's declaratory judgment claims - in part because it previously made a deal with the generic Ranbaxy to block generic versions of Lipitor...
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Shire plc, the global specialty biopharmaceutical company, announces that its subsidiaries Shire Development Inc. and Shire Pharmaceutical Development Inc. have filed a lawsuit in the U.S. District Court for the District of Delaware against Cadila Healthcare Limited...
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Roxane Labs announced Thursday the launch of two new generic drugs...
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Sandoz has launched a generic drug for treating migraine headaches, the generics arm of Swiss drug maker Novartis said Monday....
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SIGMA Pharmaceuticals has told South African stalker Aspen Pharmacare that it has fielded alternative offers for parts of its business.
Several "genuine" expressions of interest were being considered by Sigma's board, the local group advised the market yesterday.
News of the potential carve-up comes less that a week after Aspen, which has been conducting due diligence on a potential acquisition, lowered its offer price from 60c to 55c a share....
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Generic drug maker Watson Pharmaceuticals hopes to be the first to market a version of a kidney disease treatment made by Genzyme, Watson said Monday....
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Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Nabumetone Tablets USP, 500 mg and 750 mg....
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Mylan Inc. today announced plans to acquire Bioniche Pharma Holdings Limited, a privately held, global injectable pharmaceutical company for $550 million in cash. Bioniche Pharma will provide Mylan not only an immediate entry into the North American injectables market but also a platform for future growth opportunities....
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Teva Pharmaceuticals has launched a drug for treating migraine headaches, the generic drug maker said....
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Gilead Sciences, Inc. today announced that it has filed a lawsuit in U.S. District Court in New Jersey against Lupin Limited for infringement against Gilead's patents for Ranexa(R) (ranolazine extended-release tablets)....
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Perrigo Company announced its filing with the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Clobetasol Propionate Emulsion Foam, 0.05% and notified Stiefel Research Australia Pty. Ltd., the listed patent owner. Perrigo believes it is first-to-file on this product....
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Recombinant Follicle Stimulating Hormone (rFSH) would expand Watson's global presence in women's health, capitalize on Watson's Eden Biodesign biologics capabilities....
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Sun Pharmaceutical Industries Ltd. announced that USFDA has granted approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Flomax, tamsulosin capsules....
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Sun Pharma announced that the U.S. District Court for the District of New Jersey denied its motion for judgment as a matter of law seeking to reverse the earlier jury verdict in the patent litigation over generic Protonix....
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. District Court for the District of New Jersey denied Teva's motion to overturn an April 23, 2010, jury verdict finding the patent in suit not invalid....
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Glenmark Pharmaceuticals Ltd. on Wednesday said a unit has received an approval from the U.S. Food and Drug Administration to sell a generic version of Purdue Pharmaceutical Products LP's Uniphyl for the treatment of respiratory disorders....
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Nycomed announced today that Judge Jose L. Linares of the U.S. District Court for the District of New Jersey has confirmed the jury verdict in favor of Nycomed and Pfizer Inc....
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Mylan Inc. today announced that its subsidiary Mylan Technologies Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Clonidine Transdermal System USP, 0.1 mg/day, 0.2 mg/day and 0.3 mg/day, the generic version of Boehringer Ingelheim's Catapres-TTS(R), a treatment for hypertension....
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Generics maker Teva Pharmaceuticals USA Inc. has agreed to suspend litigation over a compound patent for Eisai Co. Ltd.'s popular Alzheimer's drug Aricept, effectively ending Teva's bid to manufacture a generic version of the drug before the patent expires in November....
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Generic drug maker Caraco Pharmaceutical Labs has launched a generic antidepressant, Caraco said Wednesday....
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Actavis today announced that it has received approval from the FDA to market Bupropion HCl Extended-Release (SR) tablets 100mg and 200mg. Distribution of the product will commence immediately....
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Forest Laboratories Holdings, Ltd., Merz Pharma GmbH & Co. KGaA, and Merz Pharmaceuticals GmbH announced today that they have entered into settlement agreements with all remaining defendants in patent infringement litigation related to Forest's NAMENDA(R) (memantine hydrochloride) immediate release tablets....
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Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited received final approval on July 20 from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Minocycline Hydrochloride Extended Release Tablets (Minocycline ER), 45 mg, 90 mg and 135 mg, the generic version of Solodyn(R) ER, a treatment for acne, sold by Medicis Pharmaceuticals Corporation (Medicis)....
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Impax Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for the generic version of OPANA(R) ER (oxymorphone hydrochloride) Extended Release 30mg tablet....
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Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited received final approval on July 20 from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Minocycline Hydrochloride Extended Release Tablets (Minocycline ER), 45 mg, 90 mg and 135 mg, the generic version of Solodyn(R) ER, a treatment for acne, sold by Medicis Pharmaceuticals Corporation (Medicis)....
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Momenta Pharmaceuticals, Inc., a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that the U.S. Food and Drug Administration has granted marketing approval of the Abbreviated New Drug Application (ANDA) for enoxaparin sodium for injection filed by Sandoz....
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Glenmark Generics Inc., USA (GGI), a subsidiary of Glenmark Generics Ltd, announced today that the United States Food and Drug Administration (U.S. FDA) has granted tentative approval for Fluocinonide 0.1% cream, the generic version of Medicis's Vanos cream....
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Glenmark Generics Inc., USA, a subsidiary of Glenmark Generics Ltd, today announced they have been granted final approval by the United States Food and Drug Administration (U.S. FDA) for Norethindrone tablets 0.35mg, their generic version of Micronor tablets by Ortho McNeil Janssen Pharmaceuticals, Inc....
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Statement from the Generic Pharmaceutical Association (GPhA) on testimony of FTC Commissioner Jon Leibowitz before the U.S. House of Representatives Committee on the Judiciary, Subcommittee on Courts and Competition Policy. "The FTC's testimony fails to present the whole story regarding patent settlements...
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Europe's top competition regulator has accused French pharmaceutical company Servier of providing "incorrect and misleading" information during a Brussels probe into the drugs sector...
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Biotechnology company Momenta Pharmaceuticals Inc. said Tuesday a federal court placed no restrictions on the sale of a generic version of Sanofi-Aventis SA's Lovenox...
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Tris Pharma, a specialty pharmaceutical company that develops innovative drug delivery technologies, announced that the US Food and Drug Administration (FDA) has approved a first-time generic of Methylphenidate Hydrochloride...
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Sanofi-Aventis SA, France's leading drugmaker, sued the U.S. Food and Drug Administration to make it withdraw clearance of a lower-cost rival to the company's Lovenox blood thinner....
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Portions of an Eli Lilly patent for cancer drug and infection-fighter Gemzar are invalid, a federal court ruled on Wednesday...
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Cephalon Inc. has asked the U.S. Food and Drug Administration to withdraw its acceptance of Watson Pharmaceuticals Inc.'s application to market a copycat version of Cephalon's pain drug Fentora...
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Glenmark Generics Inc., USA , the United States subsidiary of Glenmark Generics Ltd, announced today that the United States Food and Drug Administration (U.S. FDA) has granted tentative approval for Riluzole 50 mg tablets, the generic version of Rilutek tablets by Sanofi Aventis US LLC....
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Perrigo Company announced that it has filed with the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) for butoconazole nitrate vaginal cream, 2% and that is has notified KV Pharmaceutical Company, the owner of the New Drug Application (NDA) as well as FemmePharma, the listed owner of the patent, of its ANDA filing....
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Strides Arcolab Limited (Strides) today announced that the U.S. Food and Drug Administration has granted approval of Sumatriptan Succinate Injection 6 mg (base)/0.5 mL, a selective agonist for a vascular 5-hydroxytryptamine1 receptor subtype....
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Strides Arcolab Limited (Strides) today announced that the U.S. Food and Drug Administration has granted approval of Rocuronium Bromide 10mg/ml-5ml and 10 ml multi dose vials, a nondepolarizing neuromuscular blocking agent....
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Glenmark Generics Inc., USA (GGI), the United States subsidiary of Glenmark Generics Limited (GGL) has commenced marketing and distribution of Cyclobenzaprine Hydrochloride tablets in the U.S. market....
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